A Prospective Longitudinal Assessment of PD Functional Impairment and Disability Via Mobile Health Technology

July 16, 2023 updated by: Rush University Medical Center

A Prospective Longitudinal Assessment of Parkinson's Disease Functional Impairment and Disability Via Mobile Health Technology

The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in Parkinson's disease patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mobile health technologies include the wearable sensor technologies that are body-worn and passively collect information and mobile devices like smartphones that can be frequently used by patients to actively or passively collect information. However, there has been limited comparison of different wearable technologies to validated clinical rating scales to allow us to come to a consensus about their utility in both clinical practice and research trials. Data from mobile health technologies in Parkinson's Disease (PD) have not been validated to use in the place of clinician rating scales. It is also not clear if the information obtained with the devices consistently correlates with change on the clinician scales and longitudinal motor decline. Technological challenges, such as the feasibility (safety, compliance) of use devices in patients with neurodegenerative disease, change in equipment and algorithms over time, collaboration with companies who may own patents, and other issues may also limit their use in healthcare and research. The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in PD patients. The hypothesis is that there will be an association between data from mobile health technologies and data obtained from validated questionnaires/scales, indicating that these technologies are a reliable means of monitoring motor symptomatology and functional impairment and disability over time. The primary aims of the study are to compare information on continuously-measured patient-reported PD-related functional impairment and disability changes from traditional validated questionnaires to continuously-measured health-related data from a battery of novel mobile health technologies, and to assess the feasibility (compliance, safety, satisfaction) of PD patients to use a battery of novel mobile health technologies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

20 patients with Parkinson Disease who are currently on levodopa treatment will be included in the study cohort. They must meet the inclusion/exclusion criteria.

Description

Inclusion Criteria:

  • PD as defined by the UK Brain Bank Criteria
  • Disease duration between 2-13 years
  • Aged 35-68 years
  • Hoehn & Yahr stage 3 or less when in the levodopa-"ON" state

Exclusion Criteria:

  • Atypical parkinsonism including 18F-dopa PET patterns consistent with this
  • MMSE score of < 24 or evidence for dementia using DSM-IV criteria
  • Unable to do normal copying of interlocking pentagons and semantic fluency score <20 over 90 secs
  • Ongoing major medical or psychiatric disorder including depression and psychosis
  • Other concomitant treatment with neuroleptics
  • Significant drug induced dyskinesias (>2 for any body part on the AIMS scale)
  • Previous neurosurgery Unable to be imaged using MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Parkinson Disease patients
To examine the relationship between in-home continuous measures of tremor, bradykinesia, mobility, and dyskinesia acquired over a 7-day period, from 2 mobile health technologies (Personal Kinetigraph, Kinesia 360) with one-time in-clinic measures of motor functional ability pertaining to the same 7-day period as assessed by Part 2 of the MDS-UPDRS, Part 4 of the MDS-UPDRS, Neuro-QOL, and PDQ-39. This will be examined in n=20 patients (10 patients assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks). Patients will then be following for an observational period of an additional 6 months.
Device: Personal Kinetigraph, Kinesia 360
10 patients will be assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Personal Kinetigraph
Time Frame: 3 months
Watch containing accelerometer and gyroscope for measurement of motor symptoms of PD
3 months
Kinesia 360
Time Frame: 3 months
2 sensor straps to wrist and ankle containing accelerometer and gyroscope for measurement of motor symptoms of PD.
3 months
MDS-UPDRS
Time Frame: 6 months
Part I assesses the non-motor aspects of experiences of daily living in the week prior to the visit. Part II assesses the motor aspects of experiences of daily living in the week prior to the visit. Part III assesses motor disabilities of a subject at the time of the visit and Part IV assesses motor complications in the week prior to the visit. A total of 46 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deborah A Hall, MD,PhD, Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20100709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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